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Trial record 1 of 1 for:    prediphone
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Effectiveness of a Nurse-led Personalized Telephone Intervention on Lifestyle Changes in Diabetes Prevention. (PREDIPHONE)

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ClinicalTrials.gov Identifier: NCT04735640
Recruitment Status : Active, not recruiting
First Posted : February 3, 2021
Last Update Posted : October 26, 2022
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Josep1, University of the Balearic Islands

Study Description
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Brief Summary:
A randomized, 9-months, parallel-group study comparing the effectiveness of a nurse-led telephone personalized lifestyle intervention versus automated SMSs on nutritional and physical activity advice in the reduction of fasting blood glucose and/or HbA1c in a population with prediabetes.

Condition or disease Intervention/treatment Phase
Prediabetic State Behavioral: nurse-led teleconsultation Behavioral: SMS Not Applicable

Detailed Description:
It is estimated that about 70% of the prediabetic population will eventually develop type 2 diabetes (T2DM), contributing to the significant economic burden on health systems and societies. When prediabetes is recognized, lifestyle intervention including weight loss through diet and exercise can reduce the relative risk of developing T2DM by more than 50% within 3 years. In the context of the current pandemic caused by COVID-19 the implementation of prevention strategies is heavily affected. Telemedicine consultations give patients the opportunity to receive personalized advice on disease prevention even in times of pandemic. Previous studies on telemedicine intervention strategies for the prevention of T2DM show that there is a need to further explore the utility of telemedicine and especially telephone-based personalized behavioural interventions in patients with prediabetes.The aim of the present research is to determine whether a nurse-led personalized telephone lifestyle intervention is effective in reducing risk factors associated with the development of T2DM in subjects with prediabetes, versus automated short message service (SMS).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of a 9-months Nurse-led Telephone Personalized Lifestyle Intervention Versus Automated SMSs on Nutritional and Physical Activity Advice on Glucose Profile in Patients With Prediabetes
Actual Study Start Date : April 13, 2021
Estimated Primary Completion Date : February 28, 2023
Estimated Study Completion Date : October 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Arms and Interventions
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Arm Intervention/treatment
Experimental: Nurse-led teleconsultation group
9-month nurse-led telephone-based personalized behavioural intervention.
 Behavioral: nurse-led teleconsultation
Patients assigned to this group will receive personalized dietary and physical activity advice during 9 months. Behavioural goals and action plans will be developed in a stepwise manner in accordance with baseline levels of nutritional and physical activity adherence to recommendations.
Active Comparator: SMS group
Behavioural intervention by means of short text messages.
 Behavioral: SMS
Patients assigned to this group will receive a total of 150 text messages (4 to 5 messages per week during weekdays) throughout the intervention period (9 months). The content of the text messages includes advice on diet and exercise.


Outcome Measures
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Primary Outcome Measures :
  1. Change in fasting plasma glucose [ Time Frame: at baseline, 4, 9, and 15 months ]
    Change in fasting plasma glucose at 4, 9, and 15 months versus baseline


Secondary Outcome Measures :
  1. Blood levels of HbA1c [ Time Frame: at baseline, 4, 9, and 15 months ]
    Change in HbA1c levels at 4, 9, and 15 months versus baseline

  2. Maintenance of acquired dietary and physical activity changes [ Time Frame: 15 month ]
    Whether lifestyle changes acquired during the 9-month active-intervention phase are maintained in the mid-term.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Fasting plasma glucose between 100 and 125 mg/dL OR HbA1c between 5.7 and 6.4%
  • BMI ≥ 27 and < 40 kg/m2
  • Written informed consent

Exclusion Criteria:

  • Documented history of T2DM or use of oral antidiabetic medication
  • Terminal illness
  • Institutionalization, dementia or cognitive impairment
  • Pregnancy
  • Major surgery or hospital stay during the previous 3 months
  • Documented history of hematologic disease which may interfere with the HbA1c measurement
  • Presence of any medical or psychological condition that may limit the ability of the patient to participate in the study
  • Concomitant active participation in another clinical trial
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04735640


Locations
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Spain
University of the Balearic Islands
Palma De Mallorca, Balearic Islands, Spain, 07122
Sponsors and Collaborators
University of the Balearic Islands
Instituto de Salud Carlos III
Investigators
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Principal Investigator: Miquel Bennasar Veny, PhD University of the Balearic Islands
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Josep1, PhD, University of the Balearic Islands
ClinicalTrials.gov Identifier: NCT04735640    
Other Study ID Numbers: PI18/01209
First Posted: February 3, 2021    Key Record Dates
Last Update Posted: October 26, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Josep1, University of the Balearic Islands:
prediabetes
type 2 diabetes
fasting plasma glucose
 diet
physical activity
randomized clinical trial
Additional relevant MeSH terms:
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Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases